CN114470488B

CN114470488B - Balloon catheter

Info

Publication number: CN114470488B
Application number: CN202011272118.1A
Authority: CN
Inventors: 寸雨曦; 刘云云; 刘玉梅; 孙莉
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2020-11-13
Filing date: 2020-11-13
Publication date: 2023-08-11
Anticipated expiration: 2040-11-13
Also published as: EP4233974A1; WO2022100403A1; US20240001089A1; CN114470488A; EP4233974A4

Abstract

The present invention provides a balloon catheter comprising: a tubular member and a balloon; the tubular element comprises an inner tube and an outer tube, the balloon is fixed on the tubular element, the balloon has an expanded state and a contracted state, the outer tube is sleeved outside the inner tube, and a first cavity is formed between the outer tube and the inner tube; the outer tube comprises an outer tube main body and a first concave part, the first concave part is positioned at the distal end of the outer tube main body, the outer diameter of the first concave part is smaller than that of the outer tube main body, the inner diameter of the first concave part is smaller than that of the outer tube main body, and the proximal end of the balloon is fixedly connected with the first concave part; the inner tube includes an inner tube body and a second recess located at a distal end of the inner tube body, the second recess having an outer diameter smaller than an outer diameter of the inner tube body. The balloon catheter configured in this way has good compatibility, small pushing force in the conveying process and low irritation to the vessel wall.

Description

Balloon catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon catheter.

Background

Balloon catheters generally comprise a tubular element with a lumen and an inflatable and deflatable balloon, which in the field of interventional therapy function to dilate stenosis, dilate stents, occlude the neck of an aneurysm, occlude blood flow.

In some balloon catheter products in the prior art, the balloon is generally arranged outside the outer catheter, and because the balloon itself has a certain thickness, in order to ensure that the balloon catheter can be smoothly pushed in the blood vessel, the outer diameter of the balloon catheter needs to be controlled so as not to be too large, so that the inner diameter of the balloon catheter is too small or the liquid passing cavity is too small, and the balloon catheter cannot be compatible with larger medical equipment, or the balloon catheter is too long in expansion and contraction time, so that the treatment time is influenced. Meanwhile, the balloon is arranged outside the outer tube, so that the far end of the balloon catheter is harder, the pushing force is large in the conveying process, the irritation to the blood vessel wall is strong, the overbending capability is poor, and the reaching capability is limited.

The above disadvantages limit the therapeutic effect of the balloon catheter, increase the difficulty of the operation and bring great risks to the patient.

Disclosure of Invention

The invention aims to provide a balloon catheter, which solves the problems of poor compatibility, large pushing force in the conveying process and strong irritation to the vessel wall in the existing balloon catheter.

In order to solve the above technical problems, the present invention provides a balloon catheter, which includes:

a tubular member and a balloon; the tubular element comprises an inner tube and an outer tube, the balloon is fixed on the tubular element, the balloon has an expanded state and a contracted state, the outer tube is sleeved outside the inner tube, and a first cavity is formed between the outer tube and the inner tube;

The outer tube comprises an outer tube main body and a first concave part, the first concave part is positioned at the distal end of the outer tube main body, the outer diameter of the first concave part is smaller than that of the outer tube main body, the inner diameter of the first concave part is smaller than that of the outer tube main body, and the proximal end of the balloon is fixedly connected with the first concave part;

the inner tube includes an inner tube body and a second recess located at a distal end of the inner tube body, the second recess having an outer diameter smaller than an outer diameter of the inner tube body.

Preferably, the first recess comprises, in order from the proximal end to the distal end, a first transition zone and a first straight zone, the first transition zone being a reducing zone where the inner and outer diameters of the outer tube become smaller.

Preferably, the axial length of the first transition zone is 0mm-10mm.

Preferably, the inner and outer surfaces of the first transition zone are inclined at the same angle as the axial direction of the outer tube body, the angle of inclination being 0 ° -90 °.

Preferably, the ratio of the outer diameter of the first flat region to the outer diameter of the outer tube body is 0.7-1.0.

Preferably, the outer diameter of the outer tube body is 1.0mm to 3.7mm and the outer diameter of the first flat region is 0.7m to 3.5mm.

Preferably, the outer tube further comprises an outer tube distal portion located distally of the first recess, the outer diameter of the outer tube distal portion proximal to the outer tube distal portion being greater than the outer diameter of the distal end of the first recess, the outer tube distal portion being fixedly connected to the inner tube at a distal location.

Preferably, the distal end portion of the outer tube comprises a second transition region and a second straight region in this order from the proximal end to the distal end, the second transition region being a variable diameter region where the outer diameter of the outer tube becomes larger.

Preferably, the second recess comprises, in order from the proximal end to the distal end, a third transition zone and a third flat zone, the third transition zone being a reducing zone where the outer diameter of the inner tube becomes smaller.

Preferably, the axial length of the second recess is 2-60mm.

Preferably, the outer surface of the third transition zone forms a certain inclination angle with the axial direction of the inner pipe main body, the inclination angle is 0-90 degrees, and the axial length of the third transition zone is 0-10mm.

Preferably, the ratio of the outer diameter of the third flat region to the outer diameter of the inner tube body is 0.6 or more and less than 1.0.

Preferably, the outer diameter of the inner tube body is 0.5mm-3.2mm, and the outer diameter of the third flat region is 0.3mm or more and less than 3.2mm.

Preferably, the inner tube further comprises an inner tube distal portion, the inner tube distal portion being located distal to the second recess.

Preferably, the axial length of the distal end portion of the inner tube is 1-500mm.

Preferably, the outer diameter of the distal end portion of the inner tube is smaller than the outer diameter of the second recess, the distal end portion of the inner tube being located at the head end of the balloon catheter.

Preferably, the distal end portion of the inner tube comprises, in order from the proximal end to the distal end, a fourth transition zone and a fourth straight zone, the fourth transition zone being a variable diameter zone where the outer diameter of the inner tube becomes smaller.

Preferably, the fourth flat region has an outer diameter of 0.2mm to 3.1mm.

Preferably, the most distal end of the outer tube body is referred to as a first transition position; the most distal end of the inner tube body is referred to as the second transition position; the second transition position is located proximal to the first transition position.

Preferably, the first recess comprises a first transition region and a first flat region in sequence from the proximal end to the distal end; the second concave part sequentially comprises a third transition area and a third straight area from the proximal end to the distal end;

the outer surface of the third transition zone and the axial direction of the tubular element form a first inclination angle, and the inner surface of the first transition zone and the axial direction of the tubular element form a second inclination angle, and the first inclination angle is larger than or equal to the second inclination angle.

Preferably, the distance between the projection of the second transition position in the axial direction of the tubular element and the projection of the first transition position in the axial direction of the tubular element is between 10mm and 80mm.

Preferably, the distance between the projection of the second transition position in the axial direction of the tubular element and the projection of the first transition position in the axial direction of the tubular element is 20mm-60mm.

Preferably, the distance between the projection of the second transition position in the axial direction of the tubular element and the projection of the first transition position in the axial direction of the tubular element is 30mm-45mm.

Preferably, the distal end of the balloon is fixedly connected to the second recess.

Preferably, the balloon is arranged in a first concave part, the proximal end and the distal end of the balloon are fixedly connected with the outer tube, the distal end of the outer tube is connected with the inner tube, and a liquid through hole for filling liquid into the balloon is formed in the first concave part.

Preferably, the material of the balloon is any one or a mixture of any two or more of silica gel, polyurethane, latex, polyethylene, polytetrafluoroethylene and expanded polytetrafluoroethylene.

Preferably, the inner tube and the outer tube at least comprise one polymer layer, and the polymer layer is made of one or more of polyether block polyamide, nylon, polyurethane, polytetrafluoroethylene, polyethylene and polyolefin elastomer.

Preferably, the outer tube and/or the inner tube further comprises a reinforcing layer, the reinforcing layer is a wire braiding structure, a wire spiral winding structure, a cut tube or a combination of any two or more of the two, and the reinforcing layer is made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy or a polymer.

Preferably, the outer tube and/or the inner tube has a three-layer structure, and the three-layer structure sequentially comprises a first polymer layer, a reinforcing layer and a second polymer layer from inside to outside.

Preferably, the inner part of the inner tube forms a second cavity, and the whole inner diameter of the second cavity is the same.

Preferably, the ratio of the inner diameter of the second cavity to the outer diameter of the outer tube body is 0.2-0.9.

Preferably, the second cavity has an inner diameter of 0.1mm-3.0mm and the outer diameter of the outer tube body is 0.5mm-3.7mm.

Preferably, the balloon has a length of 5-30mm when deflated.

Preferably, the balloon has a length of 10-20mm when deflated.

In summary, the balloon catheter provided by the present invention includes a tubular member and a balloon; the tubular element comprises an inner tube and an outer tube, the balloon is fixed on the tubular element, the balloon has an expanded state and a contracted state, the outer tube is sleeved outside the inner tube, and a first cavity is formed between the outer tube and the inner tube; the outer tube comprises an outer tube main body and a first concave part, the first concave part is positioned at the distal end of the outer tube main body, the outer diameter of the first concave part is smaller than that of the outer tube main body, the inner diameter of the first concave part is smaller than that of the outer tube main body, and the proximal end of the balloon is fixedly connected with the first concave part; the inner tube includes an inner tube body and a second recess located at a distal end of the inner tube body, the second recess having an outer diameter smaller than an outer diameter of the inner tube body.

In summary, through the balloon catheter of the present invention, at least one of the following beneficial effects can be brought:

1. the outer tube and the inner tube of the balloon catheter are provided with concave parts for accommodating at least part of the volume of the balloon, reducing the thickness of the connecting position, partially or completely eliminating the influence of the balloon on the hardness of the balloon catheter, ensuring the flexibility of the balloon catheter and enabling the balloon catheter to be smoothly pushed in the blood vessel.

2. The concave parts are arranged on the outer tube and the inner tube of the balloon catheter, so that the thickness of the whole balloon catheter is reduced, the outer diameter of the balloon catheter is controlled not to be too large while the inner cavity of the balloon catheter is ensured to be sufficiently large, the inner cavity of the balloon catheter can pass through medical equipment with larger volume, simultaneously, the balloon catheter can smoothly pass through tortuous vessels, the stimulation to the vessel wall is reduced, and the balloon catheter is positioned at a higher vessel position.

3. The proximal end of the balloon is fixed on the outer tube, and the distal end of the balloon is fixed on the inner tube, so that the influence of the existence of the balloon on the overall outer diameter of the balloon catheter and the flexibility of the catheter is further reduced.

4. The concave part is arranged on the inner tube, so that the volume of the cavity between the inner tube and the outer tube is ensured to be large enough, and the expansion and contraction rate of the balloon is ensured.

5. The transition point that external diameter begins to change on the outer tube is located the distal end of the transition point that external diameter begins to change on the inner tube, guarantees that the volume of leading to the liquid chamber can not become too little because of the internal diameter of outer tube reduces, guarantees the efficiency of liquid through or back-pumping.

6. The axial distance between the transition point of the outer diameter on the outer tube and the transition point of the outer diameter on the inner tube is in a proper range, so that the volume of the liquid passing cavity is ensured, and meanwhile, the supporting performance of the proximal end and the softness of the distal end of the balloon catheter can be ensured, and the over-bending capability and the arrival capability of the balloon catheter are good.

7. The outer diameter of the distal end of the inner tube is smaller than that of the inner tube main body at the proximal end, so that the flexibility of the catheter from the proximal end to the distal end is gradually increased, and the delivery and arrival capabilities of the catheter are ensured.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:

FIG. 1 is an overall schematic of the inflated state of a balloon catheter provided by a preferred embodiment of the present invention;

FIG. 2 is an overall schematic view of a balloon catheter according to a preferred embodiment of the present invention in a contracted state;

FIG. 3 is a cross-sectional view of a distal portion of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 4 is a cross-sectional view of a distal portion of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 5 is a cross-sectional view of a distal portion of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 6 is a cross-sectional view of a distal portion of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 7 is a cross-sectional view of a distal portion of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 8 is a schematic overall view of a balloon catheter according to a preferred embodiment of the present invention;

FIG. 9 is a cross-sectional view of a distal portion of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 10 is a cross-sectional view of a distal portion of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

in the accompanying drawings:

100: a tubular element; 200: a balloon; 101: an outer tube; 102: an inner tube; 1011: an outer tube body; 1012: a first concave portion; 1012-1: a first transition zone; 1012-2: a first flat region; 1013: a distal end portion of the outer tube; 1013-1: a second transition zone; 1013-2: a second straight region; 1014: a liquid through hole; 1021: an inner tube main body; 1022: a second concave portion; 1022-1: a third transition zone; 1022-2: a third flat region; 1023: a distal end portion of the inner tube; 1023-1: a fourth transition zone; 1023-2: a fourth flat region; 300: a first transition position; 400: a second transition position.

Detailed Description

The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" and the term "proximal" is generally employed near an end of an operator and the term "distal" is generally employed near an end of a patient near a lesion, unless the content clearly dictates otherwise.

The core idea of the invention is to provide a balloon catheter comprising: a tubular member and a balloon; the tubular element comprises an inner tube and an outer tube, the balloon is fixed on the tubular element, the balloon has an expanded state and a contracted state, the outer tube is sleeved outside the inner tube, and a first cavity is formed between the outer tube and the inner tube; the outer tube comprises an outer tube main body and a first concave part, the first concave part is positioned at the distal end of the outer tube main body, the outer diameter of the first concave part is smaller than that of the outer tube main body, the inner diameter of the first concave part is smaller than that of the outer tube main body, and the proximal end of the balloon is fixedly connected with the first concave part; the inner tube includes an inner tube body and a second recess located at a distal end of the inner tube body, the second recess having an outer diameter smaller than an outer diameter of the inner tube body.

The following description refers to the accompanying drawings.

Example 1

The present embodiment provides a balloon catheter, fig. 1 and fig. 2 are overall schematic views of the balloon catheter according to the first embodiment of the present invention, and fig. 3 is a cross-sectional view of a distal end portion of the balloon catheter according to the first embodiment of the present invention. As shown in fig. 1-3, the balloon catheter provided by the invention comprises a tubular element 100 and a balloon 200, wherein the tubular element 100 comprises an outer tube 101 and an inner tube 102, the balloon 200 is fixed on the tubular element 100, the outer tube 101 is sleeved outside the inner tube 102, and a first cavity is formed between the outer tube 101 and the inner tube 102. Balloon 200 has an inflated state and a deflated state, fig. 1 and 3 are respectively an overall schematic view and a distal portion sectional view of balloon 200 in the inflated state, and fig. 2 is an overall schematic view of balloon 200 in the deflated state, balloon 200 being convertible between the inflated state and the deflated state. As shown in fig. 3, the outer tube 101 includes an outer tube body 1011 and a first recess 1012, the first recess 1012 being located at a distal end of the outer tube body 1011, a proximal end of the balloon 200 being secured to the first recess 1012, and a distal end of the balloon 200 being secured to the inner tube 102. The fixation of the balloon 200 between the outer tube 101 and the inner tube 102 can reduce the influence of the presence of the balloon 200 on the overall outer diameter of the balloon catheter and the compliance of the balloon catheter. Meanwhile, the inner tube 102 of the balloon catheter includes an inner tube body 1021 and a second recess 1022, the second recess 1022 being located at a distal end of the inner tube body 1021, an outer diameter of the second recess 1022 being smaller than an outer diameter of the inner tube body 1021, a proximal end of the balloon 200 being fixed to the first recess 1012, and a distal end of the balloon 200 being fixed to the second recess 1022. The concave parts are arranged on the outer tube 101 and the inner tube 102 of the balloon catheter, at least part of the volume of the balloon catheter can be used for accommodating the balloon 200, the thickness of the connecting position can be reduced, the influence of the balloon on the hardness of the balloon catheter is partially or completely eliminated, the flexibility of the balloon catheter is ensured, the balloon catheter can be smoothly pushed in a blood vessel, the softness of the distal end of the balloon catheter is increased, and the conveying performance of the balloon catheter in the blood vessel is further enhanced. And, set up the concave part on the inner tube 102, can guarantee the volume of liquid chamber that leads to, prevent because the liquid chamber diminishes and bring the problem that sacculus inflation and shrink rate are low.

In this embodiment, the outer diameter of the first recess 1012 is smaller than the outer diameter of the outer tube body 1011, the inner diameter of the first recess 1012 is smaller than the inner diameter of the outer tube body 1011, and the proximal end of the balloon 200 is fixed to the outer surface of the first recess 1012.

In all embodiments, the axial length of the first recess 1012 is 2-20mm; in this embodiment, the axial length of the first recess 1012 is 12mm; in other embodiments, the axial length of the first recess 1012 is 2mm; in other embodiments, the axial length of the first recess 1012 is 5mm; in other embodiments, the axial length of the first recess 1012 is 10mm; in other embodiments, the axial length of the first recess 1012 is 15mm; in other embodiments, the axial length of the first recess 1012 is 20mm.

In all embodiments, the axial length of the second recess 1022 is 2-60mm; in this embodiment, the axial length of the second recess 1022 is 30mm; in other embodiments, the axial length of the second recess 1022 is 2mm; in other embodiments, the axial length of the second recess 1022 is 10mm; in other embodiments, the axial length of the second recess 1022 is 25mm; in other embodiments, the axial length of the second recess 1022 is 45mm; in other embodiments, the axial length of the second recess 1022 is 60mm.

As shown in FIG. 3, in this embodiment, the first recess 1012 includes, in order from the proximal end to the distal end, a first transition region 1012-1 and a first flat region 1012-2, the inner diameter of the first transition region 1012-1 transitions from the inner diameter of the outer tube body 1011 to the inner diameter of the first flat region 1012-2, the outer diameter of the first transition region 1012-1 transitions from the outer diameter of the outer tube body 1011 to the outer diameter of the first flat region 1012-2, the first transition region 1012-1 is a reducing region, and at the first transition region 1012-1, both the inner diameter and the outer diameter of the outer tube 101 become smaller.

As shown in fig. 3, the second recess 1022 includes, in order from the proximal end to the distal end, a third transition region 1022-1 and a third flat region 1022-2, the outer diameter of the third transition region 1022-1 transitions from the outer diameter of the inner tube body 1021 to the outer diameter of the third flat region 1022-2, the third transition region 1022-1 is a reducing region, and at the third transition region 1022-1, the outer diameter of the inner tube 102 becomes smaller.

As shown in fig. 3, in this embodiment, the inner and outer surfaces of the first transition region 1012-1 are inclined surfaces at an angle to the axial direction of the outer tube body 1011 (or to the tubular member 100), the same angle being 45 °. In other embodiments, the inner and outer surfaces of the first transition region 1012-1 are inclined surfaces at an angle to the axial direction of the outer tube body 1011 (or to the tubular element 100), the same angle being any one of greater than 0 and less than or equal to 90 degrees; in other embodiments, the inner and outer surfaces of the first transition region 1012-1 are inclined surfaces that are axially angled with respect to the outer tube body 1011 (or with respect to the tubular element 100), both inclined at an angle of 60 ° as well; in other embodiments, the inner and outer surfaces of the first transition region 1012-1 are inclined surfaces at an angle to the axial direction of the outer tube body 1011 (or to the tubular element 100), the same angle being 5 °; in other embodiments, the inner and outer surfaces of the first transition regions 1012-11 are inclined surfaces that are axially angled with respect to the outer tube body 1011 (or with respect to the tubular element 100), both inclined at an angle of 85 ° as well; in other embodiments, both the inner and outer surfaces of the first transition region 1012-1 are faces axially perpendicular to the outer tube body 1011 (or to the tubular element 100). In all embodiments, the axial length of the first transition region 1012-1 is 0-10mm; in this embodiment, the axial length of the first transition region 1012-1 is 4mm; in other embodiments, the axial length of the first transition region 1012-1 is 0mm; in other embodiments, the axial length of the first transition region 1012-1 is 3mm; in other embodiments, the axial length of the first transition region 1012-1 is 5mm; in other embodiments, the axial length of the first transition region 1012-1 is 8mm; in other embodiments, the axial length of the first transition region 1012-1 is 10mm.

Similar to the first transition 1012-1 of the first recess 1012, the outer surface of the third transition 1022-1 is an inclined surface at an angle of 10 ° to the axial direction of the inner tube body 1021 (or to the tubular member 100); in other embodiments, the outer surface of the third transition region 1022-1 is an inclined surface that is axially angled with respect to the inner tube body 1021 (or with respect to the tubular element 100), the angle of the inclined surface being 5 °; in other embodiments, the outer surface of the third transition region 1022-1 is an inclined surface that is axially angled with respect to the inner tube body 1021 (or with respect to the tubular element 100), the angle of the inclined surface being 15 °; in other embodiments, the outer surface of the third transition region 1022-1 is an inclined surface that is axially angled with respect to the inner tube body 1021 (or with respect to the tubular element 100), the angle of the inclined surface being 25 °; in other embodiments, the outer surface of the third transition region 1022-1 is an inclined surface that is axially angled with respect to the inner tube body 1021 (or with respect to the tubular element 100), the angle of the inclined surface being 20 °; in other embodiments, the outer surface of the third transition region 1022-1 is a surface that is axially perpendicular to the inner tube body 1021 (or to the tubular member 100). In some embodiments, the inner surface of the third transition region 1022-1 is axially parallel to the inner tube body 1021 (or to the tubular element 100), and the outer surface of the third transition region 1022-1 is an inclined surface that is axially at an angle to the inner tube body 1021 (or to the tubular element 100), which may be any angle from 0-90 °, such as 5 °,15 °,30 °,40 °,45 °,60 °,75 °,85 °; in other embodiments, the inner surface of the third transition region 1022-1 is axially parallel to the inner tube body 1021 (or to the tubular element 100), and the outer surface of the third transition region 1022-1 is a face axially perpendicular to the inner tube body 1021 (or to the tubular element 100); in other embodiments, the inner surface of the third transition region 1022-1 is inclined at an angle to the axial direction of the inner tube body 1021 (or to the tubular member 100), which may be at any angle from 0-90 °, such as 5 °,15 °,30 °,40 °,45 °,60 °,75 °,85 °; in other embodiments, the inner surface of the third transition region 1022-1 is a face axially perpendicular to the inner tube body 1021 (or to the tubular member 100). In all embodiments, the axial length of the third transition zone 1022-1 is 0-10mm; in this embodiment, the axial length of the third transition zone 1022-1 is 5mm; in other embodiments, the axial length of the third transition zone 1022-1 is 0mm; in other embodiments, the third transition zone 1022-1 has an axial length of 3mm; in other embodiments, the axial length of the third transition zone 1022-1 is 5mm; in other embodiments, the third transition zone 1022-1 has an axial length of 8mm; in other embodiments, the third transition zone 1022-1 has an axial length of 10mm.

In some embodiments, the outer diameter of the outer tube body 1011 is from 1.0mm to 3.7mm, the outer diameter of the first flat region 1012-2 is from 0.7m to 3.5mm, and the ratio of the outer diameter of the first flat region 1012-2 to the outer diameter of the outer tube body 1011 is from 0.7 to 1.0; in this embodiment, the outer diameter of the outer tube body 1011 is 2.8mm, the outer diameter of the first flat region 1012-2 is 2.6mm, and the ratio of the outer diameter of the first flat region 1012-2 to the outer diameter of the outer tube body 1011 is 0.928; in other embodiments, the outer diameter of the outer tube body 1011 is 3.7mm, the outer diameter of the first flat region 1012-2 is 2.8mm, and the ratio of the outer diameter of the first flat region 1012-2 to the outer diameter of the outer tube body 1011 is 0.757; in other embodiments, the outer diameter of the outer tube body 1011 is 3.5mm, the outer diameter of the first flat region is 3.5mm, and the ratio of the outer diameter of the first flat region 1012-2 to the outer diameter of the outer tube body 1011 is 1.0; in other embodiments, the outer diameter of the outer tube body 1011 is 1.0mm, the outer diameter of the first flat region 1012-2 is 0.7mm, and the ratio of the outer diameter of the first flat region 1012-2 to the outer diameter of the outer tube body 1011 is 0.7.

In some embodiments, the inner tube body 1021 has an outer diameter of 0.5mm-3.2mm, the third flat region 1022-2 has an outer diameter of 0.3m-3.2mm, and the ratio of the outer diameter of the third flat region 1022-2 to the outer diameter of the outer tube body 1011 is 0.6-1.0; in this embodiment, the outer diameter of the inner tube body 1021 is 2.8mm, the outer diameter of the third flat region 1022-2 is 2.4mm, and the ratio of the outer diameter of the third flat region 1022-2 to the outer diameter of the outer tube body 1011 is 0.857; in other embodiments, the outer diameter of the inner tube body 1021 is 3.2mm, the outer diameter of the third flat region 1022-2 is 3.2mm, and the ratio of the outer diameter of the third flat region 1022-2 to the outer diameter of the inner tube body 1021 is 1.0; in other embodiments, the outer diameter of the inner tube body 1021 is 0.5mm, the outer diameter of the third flat region 1022-2 is 0.3mm, and the ratio of the outer diameter of the third flat region 1022-2 to the outer diameter of the inner tube body 1021 is 0.6; in other embodiments, the outer diameter of the inner tube body 1021 is 1.0mm, the outer diameter of the third flat region 1022-2 is 0.8mm, and the ratio of the outer diameter of the third flat region 1022-2 to the outer diameter of the inner tube body 1021 is 0.8; in other embodiments, the outer diameter of the inner tube body 1021 is 2.0mm, the outer diameter of the third flat region 1022-2 is 1.8mm, and the ratio of the outer diameter of the third flat region 1022-2 to the outer diameter of the inner tube body 1021 is 0.9.

As shown in fig. 3, the first embodiment provides a balloon catheter having a first transition point 300 at the distal-most end of the outer tube body 1011. In this embodiment, the first transition location 300 is the location where the outer diameter and inner diameter of the outer tube 101 of the balloon catheter begin to change; in other embodiments, the first transition location 300 is a location where the outer diameter and/or inner diameter of the outer tube 101 of the balloon catheter begins to change. The most distal end of the inner tube body 1021 of the balloon catheter has a second transition position 400, in this embodiment, the second transition position 400 is the position where the outer diameter of the inner tube of the balloon catheter begins to change; in other embodiments, the second transition location 400 may also be a location where the outer and inner diameters of the inner tube 102 of the balloon catheter begin to change. In the balloon catheter, the first transition point 300 may be a surface having the same cross-sectional shape as the most distal position of the outer tube body 1011, and the second transition point 400 may be a surface having the same cross-sectional shape as the most distal position of the inner tube body 1021, and will be collectively referred to herein as the first transition point 300 and the second transition point 400 for convenience of description. In this embodiment, the projection of the first transition position 300 in the axial direction of the tubular element 100 is distal to the projection of the second transition position 400 in the axial direction of the tubular element 100; and in this embodiment, the outer surface of the third transition region 1022-1 is at a first incline angle to the axial direction of the tubular member 100, and the inner surface of the first transition region 1012-1 is at a second incline angle to the axial direction of the tubular member 100, the first incline angle being greater than or equal to the second incline angle. In this embodiment, the inner diameter of the outer tube 101 of the balloon catheter starts to decrease at the first transition position 300 and the outer diameter of the inner tube 102 of the balloon catheter starts to decrease at the second transition position 400, by providing that the projection of the first transition position 300 in the axial direction of the tubular element 100 is located at the distal end of the projection of the second transition position 400 in the axial direction of the tubular element 100 and that the angle of inclination of the third transition 1022-1 in the axial direction of the tubular element 100 is larger than the angle of inclination of the first transition 1012-1 in the axial direction of the tubular element 100, it is ensured that the volume of the first lumen does not become too small due to the decrease of the inner diameter of the outer tube 101, and that the efficiency of the passage or withdrawal of liquid is ensured when the first lumen is used for the passage or withdrawal of liquid.

In all embodiments, the balloon catheter overall length is 80-160cm; in this embodiment, the balloon catheter overall length is 130cm; in other embodiments, the balloon catheter as a whole has a length of 80cm; in other embodiments, the balloon catheter as a whole has a length of 160cm; in other embodiments, the balloon catheter as a whole has a length of 115cm; in other embodiments, the balloon catheter as a whole has a length of 110cm; in other embodiments, the balloon catheter as a whole has a length of 140cm; in other embodiments, the balloon catheter as a whole has a length of 150cm.

In this embodiment, the balloon 200 is a polymer film, the first cavity is used for passing or drawing back liquid, so as to control the transition between the expansion state and the contraction state of the balloon 200, the first cavity is used for passing or drawing back liquid such as contrast solution, physiological saline, etc., and when the first cavity is in the liquid filling state, the balloon 200 is in the expansion state; when the first cavity is in a vacuum state, the balloon 200 is in a contracted state. In this example, the thickness of the polymer film was 0.10mm; in other embodiments, the polymeric film has a thickness of 0.05mm to 0.15mm, such as 0.05mm,0.08mm,0.12mm,0.15mm. In this embodiment, the material of the polymer film is silica gel; in other embodiments, the polymeric film material is polyurethane; in other embodiments, the polymeric membrane material is latex; in other embodiments, the polymeric film material is polyethylene; in other embodiments, the polymeric membrane is polytetrafluoroethylene; in other embodiments, the polymeric membrane is made of expanded polytetrafluoroethylene; in other embodiments, the polymeric film is made of a mixture of polyurethane and polyethylene in a material ratio of 2:1; in other embodiments, the polymeric membrane is made of a mixture of polytetrafluoroethylene and expanded polytetrafluoroethylene in a material ratio of 1:1; in other embodiments, the polymer film is made of a mixture of silica gel, polyurethane and polyethylene in a material ratio of 1:1:1. In this embodiment, the proximal end of balloon 200 is attached to first straight region 1012-2, which may be by adhesive, tethered or fused; in other embodiments, the proximal end of balloon 200 may be attached to first transition region 1012-1 by an adhesive, a tie-down, or a fusion.

In this embodiment, the inner tube 102 has a three-layer structure, and sequentially comprises a first polymer layer, a reinforcing layer and a second polymer layer from inside to outside, wherein the first polymer layer is made of polytetrafluoroethylene, the reinforcing layer is made of a wire woven structure, the reinforcing layer is made of stainless steel, and the second polymer layer is formed by splicing polyether block polyamide, nylon, polyurethane, polyethylene and polyolefin elastomer in the axial direction; the outer tube 101 is a single polymer layer, and the material of the outer tube 101 is polyether block polyamide. In other embodiments, the inner tube 102 and the outer tube 101 are all three layers, namely, a first polymer layer, a reinforcing layer and a second polymer layer from inside to outside in sequence; in other embodiments, the inner tube 102 is a single-layer polymer structure, and the outer tube 101 is a three-layer structure; in other embodiments, the inner tube 102 is a three-layer structure and the outer tube 101 is a two-layer polymer structure. In other embodiments, the reinforcement layer of the inner tube 102 and/or the outer tube 101 is a spiral wound structure of wire; in other embodiments, the reinforcement layer of the inner tube 102 and/or the outer tube 101 is a cut tube; in other embodiments, the reinforcement layer of the inner tube 102 and/or the outer tube 101 is a combination of a braided wire structure and a spiral wire structure; in other embodiments, the reinforcement layer of the inner tube 102 and/or the outer tube 101 is a combination of a wire braid structure and a cut tubing; in other embodiments, the reinforcement layer of the inner tube 102 and/or the outer tube 101 is a combination of cut tubing and wire helical structures. In other embodiments, the material of the reinforcement layer of the inner tube 102 and/or the outer tube 101 comprises nickel titanium alloy; in other embodiments, the material of the reinforcing layer of the inner tube 102 and/or the outer tube 101 comprises cobalt chrome; in other embodiments, the material of the reinforcement layer of the inner tube 102 and/or the outer tube 101 comprises a polymer; in other embodiments, the material of the reinforcement layer of the inner tube 102 and/or the outer tube 101 is a combination of nickel titanium alloy and stainless steel; in other embodiments, the material of the reinforcement layer of the inner tube 102 and/or the outer tube 101 is a combination of nitinol and a polymer.

In this embodiment, the balloon catheter includes a first visualization ring located at the head of the balloon catheter; the balloon catheter also includes a second visualization ring positioned on the inner tube 102 at a location that is compatible with the location of the balloon 200.

In this embodiment, the interior of the inner tube 102 of the balloon catheter forms a second lumen, the overall inner diameter of which is the same. In all embodiments, the second cavity has an inner diameter of 0.1mm-3.0mm and the outer diameter of the outer tube body 1011 is 0.5mm-3.7mm; in this embodiment, the inner diameter of the second cavity is 2.3mm, the outer diameter of the outer tube body 1011 is 2.8mm, and the ratio of the inner diameter of the second cavity to the outer diameter of said outer tube body 1011 is 0.821; in other embodiments, the second cavity has an inner diameter of 0.1mm, the outer diameter of the outer tube body 1011 is 0.5mm, and the ratio of the inner diameter of the second cavity to the outer diameter of the outer tube body 1011 is 0.2; in other embodiments, the second cavity has an inner diameter of 3.0mm, the outer diameter of the outer tube body 1011 is 3.6mm, and the ratio of the inner diameter of the second cavity to the outer diameter of the outer tube body 1011 is 0.833; in other embodiments, the second cavity has an inner diameter of 2.7mm, the outer diameter of the outer tube body 1011 is 3.0mm, and the ratio of the inner diameter of the second cavity to the outer diameter of the outer tube body 1011 is 0.9; in other embodiments, the second cavity has an inner diameter of 2.5mm, the outer diameter of the outer tube body 1011 is 3.7mm, and the ratio of the inner diameter of the second cavity to the outer diameter of the outer tube body 1011 is 0.676. In this embodiment, the second lumen is for passage of a medical instrument.

In this embodiment, balloon 200 has a length of 10mm when inflated; in other embodiments, balloon 200 has a length of 5-30mm when inflated; in other embodiments, balloon 200 has a length of 5mm when inflated; in other embodiments, balloon 200 has a length of 8mm when inflated; in other embodiments, balloon 200 has a length of 15mm when inflated; in other embodiments, balloon 200 has a length of 20mm when inflated; in other embodiments, balloon 200 has a length of 24mm when inflated; in other embodiments, balloon 200 has a length of 30mm when inflated.

In this embodiment, an angular transition is provided between the outer tube body 1011 and the first recess 1012, and between the first transition region 1012-1 and the first flat region 1012-2; in other embodiments, an arc rounded transition may be provided between the outer tube body 1011 and the first recess 1012 and/or between the first transition region 1012-1 and the first flat region 1012-2. In this embodiment, the first flat region 1012-2 is a smooth surfaced flat region; in other embodiments, the first flat region 1012-2 may have a surface with a concave-convex configuration, a trough configuration, or a curved configuration, but a tubular configuration with the same overall inner and outer diameters.

In this embodiment, an angular transition is made between the inner tube body 1021 and the second recess 1022, and between the third transition region 1022-1 and the third flat region 1022-2; in other embodiments, an arc rounded transition may be provided between the inner tube body 1021 and the second recess 1022 and/or between the third transition region 1022-1 and the third flat region 1022-2. In this embodiment, the third flat region 1022-2 is a smooth surfaced flat region; in other embodiments, the third flat region 1022-2 may have a surface with a concave-convex configuration, a trough configuration, or a curved configuration, but may have a tubular configuration with the same overall inner and outer diameters.

Example two

The present embodiment provides a balloon catheter, fig. 4 is a cross-sectional view of a distal end portion of the balloon catheter provided in the second embodiment, and a balloon 200 of the balloon catheter shown in fig. 4 is in an inflated state. As shown in fig. 4, the overall structure of the balloon catheter according to the second embodiment is similar to that of the first embodiment, and is not repeated herein, but the inner tube 102 of the balloon catheter according to the second embodiment includes an inner tube body 1021, a second recess 1022, and an inner tube distal end 1023, the second recess 1022 is located at the distal end of the inner tube body 1021, the outer diameter of the second recess 1022 is smaller than that of the inner tube body 1021, the proximal end of the balloon 200 is fixed to the first recess 1012, and the distal end of the balloon 200 is fixed to the second recess 1022. The inner tube distal end 1023 is located at the distal end of the second recess 1022, the outer diameter of the inner tube distal end 1023 is smaller than the outer diameter of the second recess 1022, and the inner tube distal end 1023 is located at the head end of the balloon catheter. The existence of the inner tube distal end 1023 gradually increases the flexibility of the balloon catheter from the proximal end to the distal end, and ensures the delivery and arrival capabilities of the balloon catheter.

As shown in fig. 4, the inner tube distal end portion 1023 includes, in order from the proximal end to the distal end, a fourth transition region 1023-1 and a fourth flat region 1023-2, the outer diameter of the fourth transition region 1023-1 transitioning from the outer diameter of the third flat region 1022-2 to the outer diameter of the fourth flat region, the fourth transition region 1023-1 being a variable diameter region, the outer diameter of the inner tube 102 becoming smaller at the fourth transition region 1023-1. In some embodiments, the outer diameter of fourth flat region 1023-2 is 0.2mm to 3.1mm; in this embodiment, the outer diameter of fourth flat region 1023-2 is 2.0mm; in other embodiments, the outer diameter of fourth flat region 1023-2 is 0.2mm; in other embodiments, the outer diameter of fourth flat region 1023-2 is 1.5mm; in other embodiments, the outer diameter of fourth flat region 1023-2 is 3.1mm. In this embodiment, the outer diameter of the fourth flat region 1023-2 is smaller than the outer diameter of the second recess 1022, and the inner diameter of the fourth flat region 1023-2 is equal to the inner diameter of the second recess 1022; in other embodiments, the outer diameter of the fourth flat region 1023-2 is smaller than the outer diameter of the second recess 1022, and the inner diameter of the fourth flat region 1023-2 is larger than the inner diameter of the second recess 1022. By providing a fourth straight section 1023-2 having a smaller outer diameter than the proximal end at the distal end of the inner tube 102, the stiffness of the distal end of the balloon catheter can be further reduced, the ability of the balloon catheter to pass through the blood vessel can be enhanced, the risk of the distal end of the balloon catheter puncturing the blood vessel can be reduced, and the performance in place can be improved.

In other embodiments, inner tube distal portion 1023 may comprise 2-10 transition regions and straight regions, which are sequentially spaced apart such that the outer diameter of inner tube distal portion 1023 gradually decreases and the outer diameter of outer tube distal portion 1013 may gradually decrease from 3mm proximal to 0.6mm distal. In other embodiments, inner tube distal portion 1023 comprises 5 sequentially spaced transition regions and straight regions, with outer diameter of outer tube distal portion 1013 decreasing from 2.7mm proximal to 0.9mm distal; in other embodiments, inner tube distal portion 1023 comprises 10 sequentially spaced transition regions and straight regions, with outer diameter of outer tube distal portion 1013 decreasing from 3.0mm proximal to 0.6mm distal; in other embodiments, inner tube distal portion 1023 includes 2 sequentially spaced transition regions and straight regions, and outer tube distal portion 1013 has an outer diameter that decreases from 2.4mm proximal to 1.65mm distal. In other embodiments, the outer tube distal portion 1013 is a tapered tubular structure with a gradually decreasing outer diameter, the outer diameter of the outer tube distal portion 1013 being tapered; in some embodiments, the outer diameter of the outer tube distal portion 1013 tapers from 3mm proximal to 0.6mm distal; in some embodiments, the outer diameter of the outer tube distal portion 1013 tapers from 2.5mm proximal to 0.6mm distal; in some embodiments, the outer diameter of the outer tube distal portion 1013 tapers from 2mm proximal to 0.9mm distal.

In this embodiment, the projection of the first transition position 300 in the axial direction of the tubular element 100 (axial direction of the tubular element 100) is distal to the projection of the second transition position 400 in the axial direction of the tubular element 100 (axial direction of the tubular element 100). In some embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 10mm-80mm. In this embodiment, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 20mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 10mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 30mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 40mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 60mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 80mm. The first transition position 300 is located distally of the second transition position 400 to ensure that the volume of the lumen is not too small due to the reduced inner diameter of the outer tube 101, ensuring the efficiency of fluid passage or withdrawal. Meanwhile, the axial distance between the first transition position 300 and the second transition position 400 is in a proper range, so that the volume of the liquid passing cavity is ensured, and meanwhile, the support performance of the proximal end and the softness performance of the distal end of the balloon catheter can be ensured, so that the overbending capability and the arrival capability of the balloon catheter are good.

In this embodiment, the inner tube 102 has a three-layer structure, and a first polymer layer, a reinforcing layer, and a second polymer layer are sequentially disposed from inside to outside. The outer tube 101 is of a double-layer structure, the outer layer of the outer tube 101 is a polymer layer, the inner layer of the outer tube 101 is a reinforcing layer, and the reinforcing layer of the outer tube 101 is a cut pipe.

In this embodiment, the balloon catheter includes a second visualization ring positioned at the inner tube 102 that is compatible with the balloon 200 position.

In this embodiment, an angular transition is provided between the second recess 1022 and the inner tube distal portion 1023, and between the fourth transition region 1023-1 and the fourth flat region 1023-2; in other embodiments, a rounded transition may be provided between the second recess 1022 and the inner tube distal portion 1023, and/or between the fourth transition region 1023-1 and the fourth straight region 1023-2. In this embodiment, fourth straight region 1023-2 is a smooth surfaced straight region; in other embodiments, fourth straight region 1023-2 may be a tubular structure with a concave-convex, grooved, or curved surface, but with the same overall inner and outer diameters.

Example III

Embodiment three provides a balloon catheter, fig. 5 is a cross-sectional view of a distal end portion of the balloon catheter provided in embodiment three, and the balloon 200 of the balloon catheter shown in fig. 5 is in an inflated state. As shown in fig. 5, the overall structure of the balloon catheter according to the third embodiment is similar to that of the first embodiment, and the difference between the balloon catheter according to the first embodiment and the first embodiment is that the first transition area 1012-1 of the first recess 1012 is a reducing area perpendicular to the axial direction of the tubular element 100, that is, the outer surface and the inner surface of the first transition area 1012-1 are both 90 ° with respect to the axial direction of the tubular element 100, the axial length of the first transition area 1012-1, that is, the thickness of the tube at the location is 0.1mm, and the axial length of the first recess 1012 is 5mm.

In this embodiment, the projection of the first transition position 300 in the axial direction of the tubular element 100 is distal to the projection of the second transition position 400 in the axial direction of the tubular element 100.

In this embodiment, the balloon catheter includes a first visualization ring located at a head end of the balloon catheter; the balloon catheter also includes a second and third visualization rings disposed on the inner tube 102 opposite the balloon 200, the second visualization ring being positioned distally of the balloon 200 and the third visualization ring being positioned proximally of the balloon 200.

Example IV

Fourth embodiment provides a balloon catheter, fig. 6 is a cross-sectional view of a distal end portion of the balloon catheter provided in the fourth embodiment, and a balloon 200 of the balloon catheter shown in fig. 6 is in an inflated state. As shown in fig. 6, the overall structure of the balloon catheter provided in the fourth embodiment is similar to that of the third embodiment, and is not described herein, but is different from that of the third embodiment: in the balloon catheter provided in the fourth embodiment, the third transition region 1022-1 of the second recess 1012 is a diameter-variable region perpendicular to the axial direction of the tubular member 100, that is, both the outer surface and the inner surface of the third transition region 1022-1 are axially 90 ° to the tubular member 100, the axial length of the first transition region 1013-1 is 0.5mm, and the axial length of the first recess 1012 is 8mm. The first transition 1012-1 of the first recess 1012 is a variable diameter area perpendicular to the axial direction of the tubular member 100, i.e., the outer surface of the first transition 1012-1 is at 90 ° to the axial direction of the tubular member 100, the axial length of the third transition 1022-1 is 0mm, and the axial length of the second recess 1022 is 20mm. In this embodiment, the second recess 1022 has the same inner diameter as the inner tube body 1021, and the thickness of the distal end of the inner tube 102 is smaller than the thickness of the inner tube body 1021. In other embodiments, the outer diameter of the second recess 1022 is smaller than the outer diameter of the inner tube body 1021, the inner diameter of the second recess 1022 is larger than the inner diameter of the inner tube body 1021, and the thickness of the inner tube distal end is smaller than the thickness of the inner tube body 1021; in other embodiments, the outer diameter of the second recess 1022 is smaller than the outer diameter of the inner tube body 1021, and the inner diameter of the second recess 1022 is smaller than the inner diameter of the inner tube body 1021.

In this embodiment, the projection of the first transition position 300 in the axial direction of the tubular element 100 is distal to the projection of the second transition position 400 in the axial direction of the tubular element 100. In some embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 10mm-80mm. In this embodiment, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 25mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 15mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 45mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 65mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 75mm.

In this embodiment, the inner tube 102 has a double-layer structure, and a first polymer layer and a second polymer layer are sequentially disposed from inside to outside. The outer tube 101 has a single-layer polymer structure.

In this embodiment, the balloon catheter includes a second developing ring and a third developing ring, the second developing ring and the third developing ring are sleeved on the inner tube 102 corresponding to the position of the balloon 200, the second developing ring is located at the distal end position of the balloon 200, and the third developing ring is located at the proximal end position of the balloon 200.

In other embodiments, as shown in FIG. 7, the third transition 1022-1 is a reduced diameter region perpendicular to the axial direction of the tubular member 100 in the second recess 1022, i.e., both the outer surface and the inner surface of the third transition 1022-1 are axially 90 degrees from the tubular member 100, the axial length of the third transition 1022-1 is 0.05mm, and the axial length of the second recess 1022 is 8mm. In the first recess 1012, the inner and outer surfaces of the first transition region 1012-1 are inclined surfaces at an angle to the axial direction of the tubular element 100, the same angle being 40.

Example five

The present embodiment provides a balloon catheter, fig. 8 is an overall schematic diagram of the balloon catheter provided in the fifth embodiment of the present invention, and fig. 9 is a cross-sectional view of a distal end portion of the balloon catheter provided in the fifth embodiment of the present invention. As shown in fig. 8 and 9, the balloon catheter provided by the invention comprises a tubular element 100 and a balloon 200, wherein the tubular element 100 comprises an outer tube 101 and an inner tube 102, the balloon 200 is fixed on the outer tube 101 in the tubular element 100, the outer tube 101 is sleeved outside the inner tube 102, and a first cavity is formed between the outer tube 101 and the inner tube 102. Balloon 200 has an inflated state and a deflated state, and balloon 200 is reciprocally convertible between the inflated state and the deflated state. As shown in fig. 9, the outer tube 101 includes an outer tube main body 1011 and a first concave portion 1012, the first concave portion 1012 is located at the distal end of the outer tube main body 1011, the balloon 200 is fixed to the first concave portion 1012, the first concave portion 1012 is provided with a liquid through hole 1014, and the first cavity is used for controlling expansion and contraction of the balloon 200 by pumping back liquid; when the first lumen is in a liquid filled state, balloon 200 is in an inflated state; when the first cavity is in a vacuum state, the balloon 200 is in a contracted state. The fluid passage 1014 is configured to allow fluid in the first lumen to pass through the fluid passage 1014 and enter the balloon 200 to inflate the balloon 200 or to withdraw fluid from the balloon 200 to deflate the balloon 200. In the first to fourth embodiments, the first recess 1012 has been described in detail, and will not be described here again.

As shown in fig. 9, in this embodiment, the outer tube 101 further includes an outer tube distal end 1013, the outer tube distal end 1013 being located at a distal end of the first recess 1012, an outer diameter of a proximal end of the outer tube distal end 1013 being larger than an outer diameter of a distal end of the first recess 1012, the distal end of the outer tube distal end 1013 being fixedly connected to the inner tube 102; the outer tube distal end 1013 includes, in order from the proximal end to the distal end, a second transition zone 1013-1 and a second flat zone 1013-2, the second flat zone 1013-2 having an inner diameter larger than that of the first flat zone 1012-2, the second flat zone 1013-2 having an outer diameter larger than that of the first flat zone 1012-2, the inner and outer diameters of the second transition zone 1013-1 gradually transitioning from the inner and outer diameters of the first flat zone 1012-2 to the inner and outer diameters of the second flat zone 1013-2 from the proximal end to the distal end, the second transition zone 1013-1 being a reducing zone where both the inner and outer diameters of the outer tube 101 become larger. In other embodiments, the inner diameter of the second flat region 1013-2 is equal to the inner diameter of the first flat region 1012-2, the outer diameter of the second flat region 1013-2 is greater than the outer diameter of the first flat region 1012-2, the outer diameter of the second transition region 1013-1 gradually transitions from the outer diameter of the first flat region 1012-2 to the outer diameter of the second flat region 1013-2 from the proximal end to the distal end, the inner diameter of the second transition region 1013-1 is constant, and the second transition region 1013-1 is a reducing region where the outer diameter of the outer tube 101 is increased. The outer tube distal end 1013 and the first recess combine with a V-shaped, frame-shaped, arcuate, polygonal, irregular pattern, etc. shaped recess that may be formed on the outer tube 101. In this embodiment, both the proximal and distal ends of balloon 200 are attached to first straight region 1012-2, which may be by adhesive, tethered or fused; in other embodiments, the proximal end of balloon 200 may be connected to first transition region 1012-1 and/or the distal end of balloon 200 may be connected to second transition region 1013-1 by adhesive, bonding, or fusion.

In this embodiment, the inner and outer surfaces of the second transition 1013-1 are inclined surfaces that are at an angle to the axial direction of the tubular element 100, the same angle of inclination being 60 °. In other embodiments, the inner and outer surfaces of the second transition zone 1013-1 are inclined surfaces at an angle to the axial direction of the tubular element 100, which may be the same or different, and which may be any of angles from 0 to 90 °, such as 5 °,15 °,30 °,40 °,45 °,60 °,75 °,85 °; in other embodiments, the inner and outer surfaces of the second transition zone 1013-1 are both faces perpendicular to the axial direction of the tubular element 100; in other embodiments, the inner surface of the second transition zone 1013-1 is axially parallel to the tubular element 100, and the outer surface of the second transition zone 1013-1 is an inclined surface at an angle to the axial direction of the tubular element 100, which may be any of angles from 0 to 90 °, such as 5 °,15 °,30 °,40 °,45 °,60 °,75 °,85 °; in other embodiments, the inner surface of the second transition zone 1013-1 is axially parallel to the tubular element 100 and the outer surface of the second transition zone 1013-1 is a face axially perpendicular to the tubular element 100; in all embodiments, the axial length of the second transition zone 1013-1 is 0-10mm; in this embodiment, the axial length of the second transition zone 1013-1 is 5mm; in other embodiments, the axial length of the second transition zone 1013-1 is 0mm; in other embodiments, the axial length of the second transition zone 1013-1 is 3mm; in other embodiments, the axial length of the second transition zone 1013-1 is 8mm; in other embodiments, the axial length of the second transition zone 1013-1 is 10mm. In all embodiments, the axial length of the outer tube distal portion 1013 is 1-15mm; in this embodiment, the axial length of the outer tube distal portion 1013 is 10mm; in other embodiments, the axial length of the outer tube distal portion 1013 is 1mm; in other embodiments, the axial length of the outer tube distal portion 1013 is 8mm; in other embodiments, the axial length of the outer tube distal portion 1013 is 12mm; in other embodiments, the axial length of the outer tube distal portion 1013 is 15mm.

In all embodiments, the outer diameter of the second flat section 1013-2 is 1.0-3.7mm, in this embodiment the outer diameter of the second flat section 1013-2 is 2.8mm. In other embodiments, the outer diameter of the second flat region 1013-2 is 1.0mm; in other embodiments, the outer diameter of the second flat region 1013-2 is 2.0mm; in other embodiments, the outer diameter of the second flat region 1013-2 is 3.0mm; in other embodiments, the outer diameter of the second flat region 1013-2 is 3.7mm; .

In this embodiment, outer tube distal portion 1013 is connected to inner tube 102 (not shown in fig. 9) to close the distal end of the first lumen so that fluid passing therethrough does not leak from the distal end of the balloon catheter, thereby controlling inflation and deflation of balloon 200. Thus, the distal end of the outer tube distal portion 1013 has a reduced diameter region (not shown) that tapers in outer diameter from the proximal end to the distal end so as to be connectable to the inner tube 102. The location where the outer tube distal end 1013 is connected to the inner tube 102 may be the location of the most distal end of the inner tube 102 or may be a location within the inner tube 102.

As shown in fig. 9, the inner tube 102 of the balloon catheter provided in this embodiment includes, from the proximal end to the distal end, an inner tube body 1021 and a second recess 1022, the second recess 1022 being located at the distal end of the inner tube body 1021, the second recess 1022 having an outer diameter smaller than the outer diameter of the inner tube body 1021. In the first to fourth embodiments, the second recess 1022 has been described in detail, and will not be described here again. In other embodiments, the inner tube 102 of the balloon catheter may include an inner tube body 1021, a second recess 1022 located distally of the inner tube body 1021, and an inner tube distal portion 1023 located distally of the second recess 1022, wherein an outer diameter of the second recess 1022 is smaller than an outer diameter of the inner tube body 1021, and an outer diameter of the outer tube distal portion 1013 is smaller than an outer diameter of the second recess 1022.

In this embodiment, the projection of the first transition position 300 in the axial direction of the tubular element 100 is distal to the projection of the second transition position 400 in the axial direction of the tubular element 100. In some embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 10mm-80mm. In this embodiment, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 18mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 12mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 42mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 55mm; in other embodiments, the distance between the projection of the second transition position 400 in the axial direction of the tubular element 100 and the projection of the first transition position 300 in the axial direction of the tubular element 100 is 78mm.

In this embodiment, the inner tube 102 has a three-layer structure, and a first polymer layer, a reinforcing layer, and a second polymer layer are sequentially disposed from inside to outside. The outer tube 101 has a double-layer structure, the outer layer of the outer tube 101 is a polymer layer, and the inner layer of the outer tube 101 is a polymer layer.

In this embodiment, the balloon catheter comprises a first developing ring, the first developing ring is sleeved outside the inner tube, and the first developing ring is positioned at the head end of the balloon catheter; the balloon catheter also comprises a second developing ring, and the second developing ring is sleeved at the position of the inner tube 102 which is matched with the position of the balloon 200.

In other embodiments, as shown in fig. 10, in the distal portion 1013 of the outer tube, the second transition zone 1013-1 is a reduced diameter region perpendicular to the axial direction of the tubular member 100, i.e., both the outer surface and the inner surface of the second transition zone 1013-1 are at 90 ° to the axial direction of the tubular member 100.

In this embodiment, an angular transition is made between the first recess 1012 and the outer tube distal end 1013, and between the second transition zone 1013-1 and the second straight zone 1013-2; in other embodiments, a rounded arc transition may be provided between the first recess 1012 and the distal portion 1013 of the outer tube and/or between the second transition 1013-1 and the second flat 1013-2. In this embodiment, the second flat region 1013-2 is a smooth surfaced flat region; in other embodiments, the second flat 1013-2 may be a tubular structure with a concave-convex, a trough, or a curved surface, but with the same overall inner and outer diameters.

The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.

Claims

1. A balloon catheter, comprising: a tubular member and a balloon; the tubular element comprises an inner tube and an outer tube, the balloon is fixed on the tubular element, the balloon has an expanded state and a contracted state, the outer tube is sleeved outside the inner tube, and a first cavity is formed between the outer tube and the inner tube;

the outer tube comprises an outer tube main body and a first concave part, wherein the first concave part is positioned at the far end of the outer tube main body, the outer diameter of the first concave part is smaller than that of the outer tube main body, the inner diameter of the first concave part is smaller than that of the outer tube main body, and the near end of the balloon is fixedly connected with the first concave part;

the inner tube comprises an inner tube main body and a second concave part, the second concave part is positioned at the far end of the inner tube main body, the outer diameter of the second concave part is smaller than that of the inner tube main body, the far end of the balloon is fixedly connected with the second concave part, a second cavity is formed in the inner tube, and the inner diameter of the whole second cavity is the same;

Wherein the distal-most end of the outer tube body is referred to as a first transition position and the distal-most end of the inner tube body is referred to as a second transition position, the second transition position being located proximal to the first transition position.

2. The balloon catheter of claim 1, wherein the first recess comprises, in order from the proximal end to the distal end, a first transition region and a first straight region, the first transition region being a reducing region where the inner and outer diameters of the outer tube become smaller.

3. The balloon catheter of claim 2, wherein the first transition zone has an axial length of 0mm to 10mm.

4. The balloon catheter of claim 2, wherein the inner and outer surfaces of the first transition zone are at the same angle of inclination as the axial direction of the outer tube body, the angle of inclination being 0 ° -90 °.

5. The balloon catheter of claim 2, wherein a ratio of an outer diameter of the first flattened region to an outer diameter of the outer tube body is 0.7-1.0.

6. The balloon catheter of claim 5, wherein the outer tube body has an outer diameter of 1.0mm-3.7mm and the first flattened region has an outer diameter of 0.7m-3.5mm.

7. The balloon catheter of claim 1, wherein the second recess comprises, in order from the proximal end to the distal end, a third transition zone and a third straight zone, the third transition zone being a reducing zone where the outer diameter of the inner tube becomes smaller.

8. The balloon catheter of claim 7, wherein the second recess has an axial length of 2-60mm.

9. The balloon catheter of claim 7, wherein an outer surface of the third transition zone is inclined at an angle to the axial direction of the inner tube body, the angle of inclination being 0 ° -90 °, and an axial length of the third transition zone being 0-10mm.

10. The balloon catheter of claim 7, wherein a ratio of an outer diameter of the third straight region to an outer diameter of the inner tube body is 0.6 or greater and less than 1.0.

11. The balloon catheter of claim 10, wherein the inner tube body has an outer diameter of 0.5mm-3.2mm and the third flattened region has an outer diameter of 0.3mm or more and less than 3.2mm.

12. The balloon catheter of claim 1, wherein the inner tube further comprises an inner tube distal portion, the inner tube distal portion being distal to the second recess.

13. The balloon catheter of claim 12, wherein the axial length of the inner tube distal portion is 1-500mm.

14. The balloon catheter of claim 12, wherein an outer diameter of the inner tube distal portion is smaller than an outer diameter of the second recess, the inner tube distal portion being located at a head end of the balloon catheter.

15. The balloon catheter of claim 12, wherein the inner tube distal end portion comprises, in order from the proximal end to the distal end, a fourth transition zone and a fourth straight zone, the fourth transition zone being a reducing zone where the outer diameter of the inner tube becomes smaller.

16. The balloon catheter of claim 15, wherein the fourth straight region has an outer diameter of 0.2mm to 3.1mm.

17. The balloon catheter of claim 1, wherein the first recess comprises, in order from the proximal end to the distal end, a first transition region and a first straight region; the second concave part sequentially comprises a third transition area and a third straight area from the proximal end to the distal end;

a first inclination angle is formed between the outer surface of the third transition zone and the axial direction of the tubular element, a second inclination angle is formed between the inner surface of the first transition zone and the axial direction of the tubular element, and the first inclination angle is larger than or equal to the second inclination angle.

18. The balloon catheter of claim 17, wherein a distance between a projection of the second transition position in an axial direction of the tubular element and a projection of the first transition position in the axial direction of the tubular element is 10mm-80mm.

19. The balloon catheter of claim 18, wherein a distance between a projection of the second transition position in an axial direction of the tubular element and a projection of the first transition position in the axial direction of the tubular element is 20mm-60mm.

20. The balloon catheter of claim 19, wherein a distance between a projection of the second transition position in an axial direction of the tubular element and a projection of the first transition position in the axial direction of the tubular element is 30mm-45mm.

21. The balloon catheter of claim 1, wherein the balloon material is any one of silica gel, polyurethane, latex, polyethylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, or a mixture of any two or more thereof.

22. The balloon catheter of claim 1, wherein the inner tube and the outer tube each comprise at least one polymer layer, and the polymer layer is made of one or more of polyether block polyamide, nylon, polyurethane, polytetrafluoroethylene, polyethylene, and polyolefin elastomer.

23. The balloon catheter of claim 22, wherein the outer tube and/or inner tube further comprises a reinforcing layer, the reinforcing layer is a wire braided structure, a wire spiral wound structure, a cut tube, or a combination of any two or more thereof, and the reinforcing layer is made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or a polymer.

24. The balloon catheter of claim 22, wherein the outer tube and/or the inner tube has a three-layer structure comprising, in order from the inside to the outside, a first polymeric layer, a reinforcing layer, and a second polymeric layer.

25. The balloon catheter of claim 1, wherein a ratio of an inner diameter of the second lumen to an outer diameter of the outer tube body is 0.2-0.9.

26. The balloon catheter of claim 25, wherein the second lumen has an inner diameter of 0.1mm-3.0mm and the outer tube body has an outer diameter of 0.5mm-3.7mm.

27. The balloon catheter of claim 1, wherein the balloon has a length of 5-30mm when contracted.

28. The balloon catheter of claim 27, wherein the balloon has a length of 10-20m when contracted.